Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.

Esophageal Cancer Clinical Trial

Official title:

A Phase II Study of Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745561
• Other study ID #: HangzhouCH05
• Status: Recruiting
• Phase: Phase 2
• First received: April 18, 2016
• Last updated: April 19, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2016
• Source: Hangzhou Cancer Hospital
• Contact: Shixiu Wu, MD
• Phone: +8657186826086
• Email: wushixiu[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Hangzhou Cancer Hospital
• Study type: Interventional

Clinical Trial Summary

Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in esophageal cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma

2. Age of 18 -80

3. ECOG performance status: 0-1;

4. No treatments prior to enrollment;

5. At least one measurable lesion on CT, MRI or esophageal barium exam;

6. Normal functions of heart, lung, liver, kidney and bone marrow Blood exams qualified for chemotherapy, which included hemoglobulin =9 g/dl, neutrophil =1.5×109/L and platelet (PLT) =100×109/L, creatinine =1.5 UNL

7. Informed consent signed

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;

2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;

3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;

4. Participating in other clinical trials;

5. Pregnancy, breast feeding, or not adopting birth control;

6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities

7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endostatin
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Endostatins
Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy.
• Oxaliplatin
Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.

Radiation:
• Radiotherapy
Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks.

Locations

Country	Name	City	State
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	Response rate will be done after 3-4 weeks following the last radiotherapy session.	week 3-4	No
Secondary	Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)	Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).	year 0 - year 3	No
Secondary	Progression-free survival	Progression-free survival (PFS) will be calculated from the date of chemoradiotherapy initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.	year 0 - year 3	No
Secondary	Overall survival	Overall survival (OS) will be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.	year 0 - year 3	No